补肾养血活血中药对超促排卵周期干预作用的随机对照研究

Intervention of Controlled Ovarian Hyperstimulation Cycle by Chinese Medical Herbs for Shen Tonifying, Blood Nourishing and Activating: a Randomized Clinical Trial

目的研究补肾养血活血中药对于辅助生殖技术(assisted reproductive technique,ART)控制性超促排卵(controlled ovarian hyperstimulation,COH)周期的影响。方法采用大样本随机对照的方法,对年龄<42岁因输卵管因素、男性因素致不孕的女性患者,采用常规COH方案,中药组(184例)于促排卵周期月经第2、3天至取卵前进行补肾养血活血中药的辅助治疗,观察血清激素水平、促性腺激素(gonadotropin,Gn)用量和用药天数、获卵数、受精以及成胚胎情况,并与未用中药的对照组(184例)进行比较。结果中药组子宫内膜厚度[(10.85±1.63)mm]大于对照组[(10.50±1.49)mm](P<0.05);优质胚胎率/冻存胚胎率(48.9%/39.7%)均优于对照组(45.4%/35.8%),差异有统计学意义(P<0.05);人类绒毛膜促性腺激素(human chorionic gonadotrophin,hCG)注射日,血清雌二醇(E2)、血清孕酮(P)、血清促黄体生成素(LH)水平,Gn用量和使用天数、获卵总数、受精率、卵裂率等方面中药组呈现良性趋势,但与对照组比较差异无统计学意义(P>0.05)。结论补肾养血活血中药与促性腺激素配合应用于超促排周期,能够提高胚胎质量,改善子宫内膜的状态,为提高体外受精-胚胎移植的成功率奠定基础。

Objective To study the effect of Chinese medical herbs for Shen tonifying, blood nourishing and activating （CMHSTBNA） on the cycle of controlled ovarian hyperstimulation （COH） of assisted reproductive technique （ART）. Methods A large sample randomized control trial was performed. Infertility women patients, younger than 42 years （infertility due to tubal factor and/or male factor） were randomly assigned to the CMHSTBNA intervention group （abbreviated as the treated group） and the control group, 184 cases in each group. All underwent COH. Those in the treated group received assist therapy of CMHSTBNA from the menstrual period day 2-3 of COH to the day of oocytes retrieved. The serum hormone level including estrogen （E 2）, progesterone（P）, luteal hormone （LH） on the day of human chorionic gonadotrophin （hCG） administration, the medication days and dosage of gonadotropin （Gn）, the number of oocytes retrieved, the fertilization rate, and the good-quality embryo rate were observed and compared with the control group. Results The endometrial thickness on the day of oocytes retrieved was 10.85±1.63 mm in the treated group, larger than that in the control group （10.50±1.49 mm） （P0.05）. The good-quality embryo rate and the frozen rate were 48.9% and 39.7% respectively in the treated group, superior to those of the control group （45.4% and 35.8% respectively）, showing statistical difference （P0.05）. On the day of hCG administration, favorable tendency was shown in the serum levels of estradial （E 2）, progesterone （P）, luteinizing hormone （LH）, the medication days and dosage of Gn, the number of oocytes retrieved, the fertilization rate, and the cleavage rate, showing no statistical difference when compared with the control group （P0.05）. Conclusion The combined application of CMHSTBNA and gonadotrophic hormones in COH cycle could elevate the embryo quality, improve the endometrial state, thus laying foundation for successful in vitro fertilization/intracytoplasmic sperm embryo transfer.